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news.Amarin, a biopharmaceutical company, has announced that the US Food and Drug Administration (FDA) has awarded three years of marketing exclusivity to Vascepa (icosapent ethyl) capsules in connection with the 26 July 2012 approval of Vascepa pursuant to the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act.
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Such exclusivity extends through 25 July 2015 and is expected to be supplemented by a 30-month stay under the Hatch-Waxman Amendments that would be triggered after patent infringement litigation initiated by Amarin following valid notice to Amarin of the acceptance of an application to the FDA seeking approval of a generic version of Vascepa.
FDA marketing exclusivity is separate from, and in addition to, patent protection, trade secrets and manufacturing barriers to entry which also help protect Vascepa against generic competition.
Amarin president and CEO John Thero noted the company is reviewing the FDA’s reasoning for granting Vascepa three-year, rather than five-year, exclusivity, and evaluating whether to challenge the decision.
"Over the past year, Amarin has significantly bolstered its patent position for Vascepa thereby decreasing the relative value of FDA marketing exclusivity in protecting Vascepa. Amarin now has 40 issued and allowed U.S. patents that provide the primary means to protect the exclusivity of Vascepa to 2030.
"These patents, all but two of which expire in 2030, are anticipated to protect the exclusivity of Vascepa well beyond the FDA marketing exclusivity period and to augment the protection afforded by Amarin’s trade secrets and existing manufacturing barriers to entry," Thero added.